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- Ensaio Clínico NCT03183479
The Effects of Fibrinogen Concentrate Infusion on Blood Loss and Allogeneic Blood Conservation in Scoliosis Surgery
The Effects of Fibrinogen Concentrate Infusion on Perioperative Blood Loss and Allogeneic Blood Conservation in Patients Undergoing Scoliosis Surgery
Visão geral do estudo
Status
Condições
Intervenção / Tratamento
Descrição detalhada
This is a prospective, randomized, double-blinded, placebo controlled trial to evaluate the effects of fibrinogen concentrate infusion on perioperative blood loss and the amount of perioperative allogeneic blood transfusion in patients undergoing scoliosis surgery.
Recently, the inherent risks of blood, along with the continued rise in blood costs, activated the development and use of alternatives to blood transfusion. Fibrinogen concentrate may limit postoperative bleeding and lead to a significant reduction in allogeneic blood products transfusions in cardiac surgery and craniosynostosis surgery. However, the effect of fibrinogen concentrate in scoliosis surgery is still uncertain. Therefore, a prospective, randomized trial is designed to evaluate if the infusion of fibrinogen concentrate may reduce allogeneic blood transfusion in patients undergoing scoliosis surgery.
Patients older than 12y/o with adolescent idiopathic scoliosis planed for elective posterior scoliosis correction surgery will be enrolled for this study after informed consent. Patients will be randomly assigned to a treatment group or a control group. Functional fibrinogen will be measured using TEG 5000 (Haemoscope Corp, IL, USA) at the start of surgery and the results of FLEV and MA will be recorded. After pedicle screw placement, a second functional fibrinogen will be measured and the patients in treatment group will receive fibrinogen concentrate (FIBRORAAS, Shanghai RAAS Blood Products Co, Ltd, Shanghai, China) 30mg kg-1. For safety concern, the maximum fibrinogen concentrate administration for each individual shall not exceed either 2g. Patients in the control group will receive placebo treatment with normal saline. After 15 minutes from fibrinogen concentrate or placebo administration, a third functional fibrinogen measurement will be performed to assess the effect of treatment. The following treatment will be guaranteed by the standard protocol in the presence of ongoing bleeding.
Data includes all the demographics, preoperative conditions, procedure details, intraoperative data, and outcome measurements will be recorded. Additional data including FLEV and MA value, as well as fibrinogen values both preoperatively and at the arrival at wards. The primary endpoint of this study will be the total perioperative blood loss, and secondary endpoints will include: perioperative blood loss per fused level, intraoperative blood loss per fused level, the amount of postoperative drainage, the amount of postoperative drainage per fused level, total units of perioperative allogeneic pRBCs transfused, total volume of FFP transfused, total PLT units transfused. Safety endpoints will include operative mortality and perioperative thromboembolic complications.
Tipo de estudo
Inscrição (Real)
Estágio
- Fase 4
Contactos e Locais
Locais de estudo
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Beijing
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Beijing, Beijing, China, 100730
- Peking Union Medical College Hospital
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Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Descrição
Inclusion Criteria:
- patients diagnosed as adolescent idiopathic scoliosis
- planed for elective posterior scoliosis correction surgery at Peking Union Medical College Hospital
Exclusion Criteria:
- preoperative anemia
- preoperative congenital or acquired coagulopathy
- ongoing anticoagulation therapy or drug intake that could cause bleeding
- clinical signs or diagnosis of acute thromboembolism
- emergency surgery
- redo surgery
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Prevenção
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Triplo
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
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Experimental: Treatment group
The patients in treatment group will receive Fibrinogen Concentrate Human administration.
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After start of surgery when all pedicle screws are placed, the patients in treatment group will receive fibrinogen concentrate 30mg kg-1.
For safety concern, functional fibrinogen will be measured and the maximum fibrinogen concentrate administration for each individual shall not exceed 2g.
Fibrinogen concentrate will be diluted in 100mL of sterile water and then be administered to patients.
Outros nomes:
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Comparador de Placebo: Control group
The patients in control group will be administered with normal saline solution as placebo.
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100mL normal saline will be administered to patients in control group as placebo
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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
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Perioperative blood loss
Prazo: hospital stay up to 30 days
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the total amount of intraoperative and postoperative blood loss
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hospital stay up to 30 days
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Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
---|---|---|
Perioperative blood loss per fused level
Prazo: hospital stay up to 30 days
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amount of intraoperative and postoperative blood loss divided by the number of surgical fused levels
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hospital stay up to 30 days
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Intraoperative blood loss
Prazo: From the time of skin incision until wound closure, assessed up to 12 hours
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the amount of intraoperative blood loss
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From the time of skin incision until wound closure, assessed up to 12 hours
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Intraoperative blood loss per fused level
Prazo: From the time of skin incision until wound closure, assessed up to 12 hour
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amount of intraoperative blood loss divided by the number of surgical fused levels
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From the time of skin incision until wound closure, assessed up to 12 hour
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Postoperative drainage
Prazo: hospital stay up to 30 days
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the amount of postoperative drainage
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hospital stay up to 30 days
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Postoperative drainage per fused level
Prazo: hospital stay up to 30 days
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amount of postoperative drainage divided by the number of surgical fused levels
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hospital stay up to 30 days
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Perioperative allogeneic red blood cell (RBC) transfusion
Prazo: hospital stay up to 30 days
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total units of RBC transfused perioperatively
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hospital stay up to 30 days
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Perioperative plasma transfusion
Prazo: hospital stay up to 30 days
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total volume of plasma transfused perioperatively
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hospital stay up to 30 days
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Perioperative platelets transfusion
Prazo: hospital stay up to 30 days
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total units of platelets transfused perioperatively
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hospital stay up to 30 days
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Colaboradores e Investigadores
Patrocinador
Publicações e links úteis
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Real)
Conclusão Primária (Real)
Conclusão do estudo (Real)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Real)
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- PUMCH-FC
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
Descrição do plano IPD
Prazo de Compartilhamento de IPD
Critérios de acesso de compartilhamento IPD
Tipo de informação de suporte de compartilhamento de IPD
- Protocolo de estudo
- Plano de Análise Estatística (SAP)
- Termo de Consentimento Livre e Esclarecido (TCLE)
- Relatório de Estudo Clínico (CSR)
- Código Analítico
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